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Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01586715
Recruitment Status : Unknown
Verified April 2012 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was:  Recruiting
First Posted : April 27, 2012
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Brief Summary:
The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.

Condition or disease Intervention/treatment Phase
Extremely Complex Perianal Fistulae Drug: Adipose-derived stem cells without expanded Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIa Clinical Trial to Study the Treatment of the Extremely Complex and Conventional Treatment Resistant Perianal Fistulae With Autologous Stem Cells From Lipoaspirate
Study Start Date : March 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Autologous Stem Cells Drug: Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls

Primary Outcome Measures :
  1. Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae [ Time Frame: 16 weeks ]
    Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound

Secondary Outcome Measures :
  1. Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16,24 weeks ]
    Test SF-12 of quality of life

  2. Adverse events [ Time Frame: 1, 4, 12, 24 weeks ]
    Control by investigation team of CRD (data collections)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • Extremely Complex perianal fistulae
  • Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
  • Previous failure in at least one closing fistula standard treatment

Exclusion Criteria:

  • Presence of severe proctitis or dominant active luminal disease requiring immediate therapy
  • Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
  • Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
  • Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
  • Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
  • Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
  • Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
  • Patients who have suffering major surgery or severe trauma in the prior 6 months
  • Pregnant or breastfeeding women
  • Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01586715

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Contact: Damián García Olmo, Prof MD 0034 912071022
Contact: Mariano A García Arranz, PhD 0034 912071022

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Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Mariano A García Arranz, PhD    0034 912071022   
Principal Investigator: Damián García Olmo, Prof MD         
Sub-Investigator: Héctor Guadalajara Labajo, MD         
Sub-Investigator: Tihomir G Hirstov, MD         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
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Principal Investigator: Damián García Olmo, Prof MD General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory
Bey NM. A new technique in dealing with superior rectovaginal fistulae. J. Obstrt Gynecol 1934. 41: 579-587
Daniels BT. Rectovaginal fistula: a clinical and pathological study. Doctoral dissertation. Minneapolis: University of Minnesota 1949
Radcliff AG, Ritchie JK, Hawley PR et al. Anal and rectovaginal fistulas in Crohn´s disease. Dis Colon Rectum. 1988; 31:91-94
García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz Identifier: NCT01586715    
Other Study ID Numbers: HULPCIR-2010-01
2010-024329-19 ( EudraCT Number )
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Extremely complex perianal fistula
Adipose Derived Stem Cells
Additional relevant MeSH terms:
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Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases